IRB #

IRB00007406

Title

An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia and DCDT2980S in Combination with Rituximab in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma

Principal Investigator

Andy Chen

Study Purpose

This phase 1 study is the first time that DCDT2980S (the study drug) is administered to humans and more specifically patients with blood cancers. Laboratory tests have shown a decrease in cancer cell growth. The purpose of this study is to test the safety, tolerability, and anti-tumor activity of the study drug, at varying strengths, in subjects with Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).

There are three stages to this study, subjects will be assigned to one of the following three stages: dose escalation, expansion, or combination of study drug and rituxan

Medical Condition(s)

Non-Hodgkins Lymphoma

Eligibility Criteria

Subjects with CLL and NHL expected to express CD22 antigen for which no standard therapy exists.
Excluding subjects that have a allogenic stem cell transplant previously, a history of other malignancy, or central nervous system lymphoma.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Until disease progression, unacceptable toxicity, voluntary subject withdrawal or investigator discretion; follow-up for one year.

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Genentech, Inc.

Recruitment End

Compensation Provided

No